NCT02539979

Brief Summary

A double blinded randomized controlled study comparing pre-procedural IV Paracetamol versus IV placebo (normal saline). The patients will be randomized to either receiving IV paracetamol or saline infusions before undergoing radiofrequency lesioning of two levels of medial branch nerves of the lumbar facets. The primary outcome will be potential differences in pain control. The secondary outcomes will be changes in quality of life (QoL) and activities of daily living (ADLs). We will also be comparing potential differences in the amounts of post-procedure pain medications taken by the patients in each wing of the study

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

September 1, 2015

Last Update Submit

April 13, 2016

Conditions

Chronic Lower Back PainLumbar Facet Syndrome

Keywords

IV ParacetamolRadiofrequency Lesion/Ablation of medial branch nervePreventative Pain Management

Outcome Measures

Primary Outcomes (1)

  • Pain Reduction

    To examine the potential impact of intravenous paracetamol on the level of pain during the 6 weeks following radiofrequency of the medial branch facet nerve

    6 weeks

Secondary Outcomes (1)

  • Change in demand for pain medication

    6 weeks

Other Outcomes (1)

  • Quality of Life and Activities of Daily Living

    6 weeks

Study Arms (2)

IV Paracetamol

ACTIVE COMPARATOR

Patients will receive 1gram of IV paracetamol mixed in 100ml infused over 15 minutes. The patients will undergo radiofrequency lesioning of two consecutive levels of lumbar facets under fluoroscopic guidance

Drug: Paracetamol

IV Placebo (Normal Saline)

PLACEBO COMPARATOR

Patients will receive 100ml of normal saline infused over 15 minutes. The patients will undergo radiofrequency lesioning of two consecutive levels of lumbar facets under fluoroscopic guidance

Drug: Placebo - Normal Saline

Interventions

ParacetamolDRUG
IV Paracetamol
Placebo - Normal SalineDRUG

Normal Saline 100cc

IV Placebo (Normal Saline)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women.
  • Age of 18+ years
  • Weight over 50 kg
  • Fits criteria for procedure-- radiofrequency ablation of medial branch facet nerve

You may not qualify if:

  • Patients who are incapable of judgment and\\or to give informed consent.
  • Pregnant or nursing.
  • Under 18 years old
  • Allergies to Paracetamol, Lidocaine, Midazolam, Depomerol
  • Chronic Paracetamol use (or products with Paracetamol- e.g.- Zaldiar) 2 weeks preoperatively.\*\*
  • Chronic NSAID use (or products containing NSAIDS) for 2 weeks pre-operatively.\*\*
  • Illicit Drug use 48 hours prior to participation.
  • Current alcohol abuse (3 or more alcoholic drinks per day)
  • Severe liver disease
  • Severe cardiac disease
  • Severe renal disease
  • Platelet dysfunction or other bleeding disorder
  • Currently unstable psychiatric disorders.
  • Primary diagnosis of fibromyalgia
  • \*\*If the patient is taking chronic pain medication other than Paracetamol or NSAIDS they may continue to take them and it will be standardized and accounted for (eg.- opioids to morphine mEq).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel, 52621, Israel

RECRUITING

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Matthew B Medwick, MD

CONTACT

054-953-8133mmedwick@gmail.com

Itay Goor-Aryeh, MD

CONTACT

03-530-4576Itay.GoorAryeh@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2016

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

IL(1)